SHELHIGH NO-REACT BIOCUFF— 510(k) K032893

Substantially Equivalent

Shelhigh, Inc.

FDA 510(k) clearance K032893 for SHELHIGH NO-REACT BIOCUFF, Substantially Equivalent on 2003-12-19. Applicant: Shelhigh, Inc..

Clearance details

Applicant: Shelhigh, Inc.
Product code: Code FTL
Advisory panel: General, Plastic Surgery
Date received: 2003-09-17
Decision date: 2003-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Union, NJ, US

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Adverse events under product code FTL

product code FTL

Death: 317
Injury: 66,072
Malfunction: 1,273
Other: 3
Total: 67,665

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.